Comparing Dopamine and Norepinephrine for Low Blood Pressure in Very Preterm Infants with Sepsis
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis: An International Comparative Effectiveness Research Project
Mount Sinai Hospital, Canada · NCT05347238
This study is testing whether Dopamine or Norepinephrine works better to help very preterm infants with low blood pressure caused by sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 21 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada (other) |
| Locations | 23 sites (Phoenix, Arizona and 22 other locations) |
| Trial ID | NCT05347238 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Dopamine versus Norepinephrine in treating fluid-unresponsive hypotension in very preterm infants suspected of having late-onset sepsis. Utilizing real-world data from the Canadian Neonatal Network, the study will analyze treatment outcomes from a large patient registry across multiple hospitals. By standardizing treatment strategies and employing a comparative effectiveness research framework, the study seeks to provide insights into the relative safety and efficacy of these commonly used medications in a vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are very preterm infants born at or before 32 weeks gestational age who are more than 48 hours old and receiving Dopamine or Norepinephrine for suspected late-onset sepsis.
Not a fit: Patients with known chromosomal or genetic anomalies or those receiving other vasopressor therapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment protocols for very preterm infants with hypotension, potentially reducing mortality rates.
How similar studies have performed: While there is limited evidence specifically for this population, comparative effectiveness research has shown promise in other settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≤32 weeks gestational age and \> 48 hours of life * Receiving primary vasopressor therapy with Dopamine or Norepinephrine in the context of suspected late-onset sepsis or necrotizing enterocolitis with systemic hypotension (defined as: culture positive or negative bloodstream infection) Exclusion Criteria: * Known chromosomal or genetic anomalies * Receiving primary therapy with agents other than Dopamine or Norepinephrine
Where this trial is running
Phoenix, Arizona and 22 other locations
- Banner-University Medical Center Phoenix — Phoenix, Arizona, United States (NOT_YET_RECRUITING)
- Dayton Children's Hospital — Dayton, Ohio, United States (RECRUITING)
- Methodist Healthcare — San Antonio, Texas, United States (RECRUITING)
- Foothill's Medical Centre — Calgary, Alberta, Canada (RECRUITING)
- BC Women's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- Victoria General Hospital — Victoria, British Columbia, Canada (RECRUITING)
- St.Boniface Hospital — Winnipeg, Manitoba, Canada (NOT_YET_RECRUITING)
- Winnipeg Health Sciences Centre — Winnipeg, Manitoba, Canada (RECRUITING)
- IWK Health Centre — Halifax, Nova Scotia, Canada (RECRUITING)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (RECRUITING)
- London Health Sciences Centre — London, Ontario, Canada (RECRUITING)
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (RECRUITING)
- Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
- Mount Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
- Windsor Regional Hospital — Windsor, Ontario, Canada (RECRUITING)
- CHU Sainte- Justine — Montreal, Quebec, Canada (RECRUITING)
- Jewish General Hospital — Montreal, Quebec, Canada (RECRUITING)
- Montreal Children's Hospital — Montreal, Quebec, Canada (RECRUITING)
- University Cork College — Cork, Ireland (RECRUITING)
- Coombe Women & Infants University Hospital — Dublin, Ireland (NOT_YET_RECRUITING)
- Shamir Medical Center — Be’er Ya‘aqov, Israel (RECRUITING)
- La Paz University Hospital — Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Amish Jain, MBBS, MRCPCH, PhD — Mount Sinai Hospital, Canada
- Study coordinator: Amish Jain, MBBS, MRCPCH, PhD
- Email: amish.jain@sinaihealth.ca
- Phone: 416-586-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension